It has been established and understood by the modern world as well as by the emerging countries, that it has become necessary to provide some sort of birth control to limit population growth.
Even in situations where the prospective mother is in full agreement that she should refrain from childbirth for at least a limited period of time, the fact is often not easily accomplished. In many regions of the world and for many individuals in other regions, the utilization of a mechanical device, such as a barrier, is unsatisfactory. The requirement of ingesting an oral contraceptive on a daily basis often does not fit into an acceptable ritual for the individual involved, particularly in a nonstructured living situation, Further, because of nutritional or health problems, predisposing anemia or diseases of the reproductive tract an intrauterine device may not be advisable in many cases.
To resolve these problems, there have been developed contraceptive steriod delivery systems requiring subcutaneous implant which, when properly administered, can provide contraception for several years. The removal and replacement of the implant may be accomplished on an outpatient basis or even in the field.
It is to be understood that although the particular instruments developed and described herein were primarily developed for utilization with contraceptives in the Third World and other emerging countries, the devices may equally be as well used for any other type of a subcutaneous system.
Historically, subcutaneous delivery systems have required the utilization of a scalpel to make an incision and a large metal trocar for placing the capsule. Prior methods have also required that each capsule be handled individually thereby greatly increasing the risk of contamination. Further, the safety of the procedure depends upon the local sterilization practices and preparation of the material.
Apparatus known to the present inventor utilized for various specialized cuts include U.S. Pat. No. 3,631,858 granted Jan. 4, 1972 to Ersek, which discloses a means for simultaneously clamping and severing the umbilical cord of a newly born infant. This device includes, as a portion thereof, a fixed blade 20 secured to a jaw such that when the jaws are closed the blade 20 slices the umbilical cord and it is clamped by the side portions of the jaw.
U.S. Pat. No. 3,302,308, granted June 6, 1967 to Hurley, is particularly designed for use in clamping or cutting an umbilical cord and/or clamping and cutting arteries or veins in surgical operations and includes a fixed blade surrounded by holding or clamping means.
U.S. Pat. No. 2,288,445 granted June 30, 1942 to Frizzell, discloses a device for marking the ear of an animal by making an incision therein and includes a pair of jaws for holding the flesh portion and relatively movable blade such that once the flesh is in position, the blade can be activated, making the desired cut.
U.S. Pat. No. 2,646,799 granted July 28, 1953 to Jacoby, discloses a blood lencet wherein a pointed knife is mounted on a resilient arm which is separately activated following the pinching of a limited amount of tissue between a pair of jaws. The jaws are spring biased outwardly.
Prior art known to the inventor which deal with the subcutaneous placement of drugs or the sterile packaging of drugs include:
U.S. Pat. No. 2,513,014 granted June 27, 1950 to Fields, which discloses a tubular needle member including a handle portion and an enlarged coaxial chamber such that a prepackaged additional tube can be placed in the enlarged coaxial chamber and a plunger utilized to push the medicinal capsule out of the prepackaged capsule, through the needle, to its resting place beneath the skin.
U.S. Pat. No. 3,402,712 granted Sept. 24, 1968 to Eisenhand, discloses a multiple pellet implanter wherein a hypodermic needle 27 is placed beneath the skin of the receiving animal and one or more pellets are introduced by activating the trigger which allows a new pellet to drop within a chamber and activate a plunger to discharge the pellet to the proper position.
U.S. Pat. No. 4,086,914 granted May 2, 1978 to Moore, discloses an implant injector including a means to interact between the inner injection carrying member and the plunger such that the plunger must be manipulated specifically to move in predetermined, spaced advances, implanting individual capsules.
U.S. Pat. No. 4,263,910 granted Apr. 28, 1981 to Pardekooper et al, discloses a sterile packaging means such that an implant tool individually penetrates a sealed cell, picking up the implantee, carrying it, without need to have human contact, to be placed within the animal by means of the sharpened tool.
With the above noted prior art and problems in mind, it is an object of the present invention to provide a presterilized packaged including a nonthreatening means for incising the flesh and a sterile, relatively flexible means for implanting one or more implantates beneath the skin.
It is another object of the present invention to provide an implant mechanism which is simple to operate and includes a means whereby the operator necessarily must perform a separate physical step for each implant, thus preventing the inadvertent implantation of more than one capsule.
Still a further object of the present invention is to provide an incisor whereby the operator need not necessarily be skilled. The configuration of the instrument is such that a predetermined amount of flesh is pinched between two blunt, jaw-like elements and, upon the application of a predetermined amount of pressure, a blade swings across the captured flesh and causes a precise incision.
Yet another object of the present invention is to provide a presterilized package for a subcutaneous inplant containing the cutter, the implanter, and the implantate such that the entire apparatus may be transported to and easily stored at remote locations without affecting the sterility.